Catalog Number

-

Brand Name

PleuraFlow® System with FlowGlide

Version/Model Number

PFFG-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163139,K163139,K163139

Product Code

OTK

Product Code Name

Wound Drain Catheter System

Public Device Record Key

a2d28304-3770-45ef-89f2-294094dc14fe

Public Version Date

March 08, 2022

Public Version Number

8

DI Record Publish Date

April 17, 2017

Package DI Number

20856449006059

Quantity per Package

1

Contains DI Package

10856449006052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case